Page 1 of 12 NATIONAL ENVIRONM EN TAL POLICY ACT DECISION

AND

FINDING OF NO SIGNIFICANT IMPACT

Pioneer Hi

- Bred International High Oleic Soybean

DP

- 305432

- 1

United States Department of Agriculture Animal and Plant Health Inspection Service

Biotechn ology Regulatory Services

United States Department of Agriculture (USDA) and t he Animal and Plant Health Inspection Service (APHIS), ha ve developed a decision document to comply with the requirements of the National Environmental Policy Act of 1969, as a mended, the Council of Environmental Quality’s (CEQ) regulations implementing NEPA, and the USDA and

APHIS ’ NEPA implementing regulations and procedures. This NEPA decision document is intended to state APHIS’ NEPA decision and present the rationale for i ts
selection.

In accordance with APHIS procedures implementing the NEPA Regulations (7 CFR part 372), APHIS has prepared an Environmental Assessment (EA) to evaluate and determine if there are any potentially significant impacts to the human environment from a determination on the regulated status of a petition request (APHIS number 06

- 354

- 01p) by Pioneer HiBred International, Inc. for DP

- 305423

- 1 (hereafter referred to as Pioneer 305423 soybean) . This Glycine max (soybean) variety was genetically engine ered to produce increased amounts of monounsaturated fatty acid (oleic) and decreased amounts of polyunsaturated fatty acids (linoleic and linolenic) and to lesser extent, decreased saturated fatty acid (palmitic acid). Pioneer 305423 contains the gm

- fad2

- 1 gene that is responsible for the unique oil profile . Pioneer 305423 a lso expresses a second gene, gm

hra, conferring tolerance to sulfonylurea herbicides which was used as a selective agent following transformation. APHIS has evaluated the plant pest risks posed by the production of Pioneer 305423 and prepared an EA to identify and evaluate any environmental impacts resulting from the approval of the petition for nonregulated status

. The EA assesses alternatives to granting nonregulated status to Pion eer 305423 and analyzes the potential environmental and social effects that result from the proposed action and the alternatives. The proposed action of USDA APHIS, Biotechnology Regulatory Services (BRS) is to grant nonregulated status to Pioneer 305423 and remove

this GE soybean variety from APHIS’ regulatory oversight in accordance with 7 CFR part 340. Comments from the public involvement process were reviewed for substantive issues which were considered in developing this NEPA decision.

In 1986, the Federal Government’s Office of Science and Technology Policy (OSTP) published a policy document known as the Coordinated Framework for the Regulation of Biotechnology. This document specifies three Federal agencies that are responsible forPage 2 of 12 regulating bio technology in the United States: USDA

- APHIS, the U.S. Department of Health and Human Services’ Food and Drug Administration (FDA), and the Environmental Protection Agency (EPA). Products are regulated according to their intended use and some products are regulated by more than one agency. USDA

- APHIS, FDA, and EPA enforce agency

- specific regulations on products of biotechnology that are based on the specific nature of each GE organism. Together, these agencies ensure that the products of modern biotechnol ogy are safe to grow, safe to eat, and safe for the

environment.

APHIS regulates GE organisms under the Plant Protection Act of 2000. USDA APHIS

BRS ’ mission is to protect America’s agriculture and environment using a dynamic and

science

- based regulator y framework that allows for the safe development and use of GE organisms. APHIS regulations at 7 CFR part 340, which were promulgated pursuant to authority granted by the Plant Protection Act, as amended (7 United States Code (U.S.C.)

7701

– 7772), regulate the introduction (importation, interstate movement, or release into the environment) of certain GE organisms and products. A GE organism is considered a regulated article if the donor organism, recipient organism, vector, or vector agent used in engineer ing the organism belongs to one of the taxa listed in the regulation (7 CFR § 340.2) and is also considered a plant pest. A GE organism is also regulated under part 340 when APHIS has reason to believe that the GE organism may be a plant pest or

APHIS doe s not have sufficient information to determine if the GE organism is unlikely to pose a plant pest risk.

A person may petition the agency to evaluate submitted data and determine that a particular regulated article is unlikely to pose a plant pest risk, a nd, therefore, should no longer be regulated, under 7 CFR § 340.6 “Petition for Determination of Nonregulated Status.” The petitioner is required to provide information (§ 340.6(c)(4)) related to plant pest risk that the agency uses to determine whether t he regulated article is unlikely to present a greater plant pest risk than the unmodified organism. After receipt of a petition, as per the requirements of § 340.6, BRS makes a determination on whether an organism

is not l ikely to pose a plant pest risk a nd is therefore no longer subject to the regulatory requirements of 7 CFR part 340. A GE organism is no longer subject to the regulatory requirements of 7 CFR part 340 when APHIS determines that it is not likely to pose a plant pest risk.

FDA regulates u nder the authority of the Federal Food, Drug, and Cosmetic Act. The FDA policy statement concerning regulation of products derived from new plant varieties, including those genetically engineered, was published in the Federal Register on May 29, 1992 (57 F R 22984

- 23005). Under this policy, FDA uses what is termed a consultation process to ensure that human food and animal feed safety issues or other regulatory issues (e.g., labeling) are resolved prior to commercial distribution of bioengineered food. The EPA regulates plant

- incorporated protectants under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and certain biological control organisms under the Toxic Substances Control Act (TSCA).Page 3 of 12 Pioneer 305423 soybean has successfully completed the consultation process with the FDA concerning food and feed safety (BNF No. 000 110 ). FDA has no more questions on nutritional or safety issues, and has provided a summary response indicating that “the food and feed derived from the 305423 soybean are a s safe and nutritious as food and feed derived from conventional soybean varieties currently being marketed.” Because Pioneer 305423 soybean does not contain any genetically engineered pesticides or tolerance to herbicides, EPA consultation is not require d.

Document History

On December 20 , 200 6 APHIS BRS received a petition from Pioneer HiBred

International seeking a determination of nonregulated status for DP

- 305423 soybean . A revised version of the petition was received on October 10, 200 7 . Upon rece ipt of the petition, BRS reviewed the information submitted and deemed the petition complete on

October 22 , 2007. Based upon information provided in the petition, BRS prepared a draft EA and Plant Pest Risk Assessment (PPRA) (USDA

- APHIS 2009)

.

Public Involvement On September 2, 2009, APHIS published a notice in the Federal Register (74 FR 45413

- 45415, Docket no. 2007

- 0156) announcing the availability of the Pioneer petition requesting non regulated status for 305423 soybean, a draft plant pest risk assessment and

a draft EA for a 60 day public comment period

. Because the original docket was not the authorized APHIS version, a subsequent 60 day comment period was published on October 26, 2009 in the Federal Reg ister (74 FR 54950

- 54951, Docket no. 2007

- 0156) announcing the availability of the corrected EA. This comment period ended on December 28, 2009. In total, 4 0 comments were received from the public during the two comment periods. All comments were analyz ed to identify new issues, alternatives, or information. Responses to the substantive comments are attached to the docket submitted to the Federal Register with this Finding of No Significant Impact

.

Major Issues Addressed in the EA

The EA describes the alternatives considered and evaluated using the identified issues. Issues considered in the EA were developed based on APHIS’ determination to grant nonregulated status for certain genetically engineered organisms and for this particular EA, the specific deregulation of Pioneer Event DP

- 305423 for production of high oleic fatty acid . The following issues were identified as important to the scope of the analysis (40 CFR 1508.25):

Soybean

**•** Gene Movement (Pollen Flow)

**•** Weediness

**•** Human Health

**•** Animal Feed Agri cultural Production of Soybean

**•** Growing Regions and Acreage

**•** Organic and Conventional Soybean Production

**•** Herbicide UsePage 4 of 12 Soybean Composition

**•** Oil Composition

**•** Soybean Meal Composition

**•** Proximate, Isoflavones and Antinutrients Impacts on Non

- target Organisms

**•** Toxic ity and Allergencity

**•** Nutrition

**•** Pest and Disease

**•** Soil Communities

**•** Threatened and Endangered Species

Affected Environment: Although the preferred alternative would allow for plantings of Pioneer 305423 soybean to occur anywhere in the U.S., APHIS limited t he environmental analysis to those areas that currently support soybean production. To determine areas of soybean production, APHIS used data from the National Agricultural Statistics Service (NASS) 2002 Census of Agriculture to determine where soybean is produced in the United States (www.nass.usda.gov, accessed 2 / 19/ 20 10 ). Only 17 states in 2008 produce d more than 1 million acres among the 31 that produced soybean according to the 2002 Census of Agriculture. Because the oil derived from this Pioneer 30 5423 soybean will likely replace that from existing soybean varieties, it is not likely that new land beyond that currently or historically used for soybean production will be planted to soybean by

growers.

Alternatives that were fully analyzed : Th e EA a nalyzes the potential environmental consequences of a proposal to grant nonregulated status to 305423 soybean

. In order for 305423 soybean to be granted nonregulated status, APHIS must determine that 305423 soybean is not likely to pose a plant pest risk. The analysis provided in the plant pest risk assessment (USDA

- APHIS

2009 ) demonstrates that there is sufficient data to determine that 305423 soybean is not likely to pose a plant pest risk and therefore is eligible for nonregulated status.

The regulati ons at 7 CFR 340.6(d)(3)(i) state that APHIS may "approve the petition in whole or in part." Because APHIS has found that 305423 soybean is not likely to pose a plant pest risk, the only alternative considered in th e EA is granting nonregulated status

“in whole” to 305423 soybean

. An “ in part ” deregulation can be given if there is a plant pest risk associated with some, but not all lines requested in a petition. The petition for Pioneer 305423 soybean only requested APHIS to grant nonregulated status to one soybean event, therefore, an “in part” determination is not an appropriate consideration. Thus, there are two alternatives that are considered in this EA: (1) no action and (2) to grant nonregulated status to 305423 soybean , “in whole.”

Alternativ e A. No Action : Continuation as a Regulated Article Under the "no action" alternative, APHIS would deny the petition. Pioneer 305423 soybeans and progeny derived from them would continue to be regulated articles underPage 5 of 12 the regulations at 7 CFR part 340. P ermits issued or notifications acknowledged by APHIS would still be required for introductions of Pioneer 305423 soybeans and measures to ensure physical and reproductive confinement would continue to be implemented. APHIS might choose this alternative if there were insufficient evidence to demonstrate the lack of plant pest risk from the unconfined cultivation of Pioneer 305423 soybeans.

Soybean breeders have achieved soybean oil compositional changes by both conventional breeding and genetic engineerin g (Fehr 2007). Under this no action alternative, growers and other parties who are involved in production, handling, processing or consumption of soybean would continue to have access to existing deregulated GE high oleic acid soybean products as well as conventional high or mid level oleic soybean varieties. However, growers would not have widespread access to soybean varieties based on Pioneer 305423 soybean since it would continue to be regulated under Part 340. There is no potential for human consump tion of Pioneer 305423 soybean high oleic acid soybean

under this alternative.

This alternative is not the preferred alternative because APHIS has already determined through a plant pest risk assessment (USDA

- APHIS, 2009) that Pioneer 305423 soybean

is unlikely to pose a plant pest risk. Choosing this alternative would hinder the purpose and need of APHIS to allow for the safe development and use of GE organisms given that Pioneer 305423 soybean is unlikely to pose a plant pest risk.

Alternative B. P referred Alternative : Grant nonregulated status to Pioneer 305423 soybean, “in whole”

- Preferred Alternative: Determination that Pioneer 305423 soybean is no longer a regulated article. Under this alternative, Pioneer 305423 soybeans and progeny derived fr om them would no longer be regulated articles under the regulations at 7 CFR part 340. Pioneer 305423 soybean is eligible for nonregulated status because APHIS has determined that this GE organism is unlikely to pose a plant pest risk (USDA

- APHIS 2009). Permits issued or notifications acknowledged by APHIS would no longer be required for introductions of high oleic acid soybeans derived from this event. APHIS might choose this alternative if there was sufficient evidence to demonstrate the lack of plant pest risk from the unconfined cultivation of high oleic acid soybeans derived from this event

.

Under this alternative, growers may have future access to Pioneer 305423 soybean and progeny derived from this variety if the developer decides to commercializ e Pioneer

305423. In addition, growers and other parties that are involved in production, handling, processing or consumption of soybean would continue to be able to use the current high or mid level oleic soybean products by conventional breeding as well as the genetically engineered soybean variety. Consumers may benefit by having access to a greater range of potentially healthful food products. By granting nonregulated status to Pioneer 305423 soybean , the purpose and need to allow the safe developmen t and use of GE organisms is met.Page 6 of 12 APHIS has chosen Alternative B as the preferred alternative for the proposed action

because APHIS has determined that Pioneer 305423 soybean is unlikely to pose a plant pest risk ( USDA

- APHIS 2009 ).

Alternatives Consi dered but Rejected from Further Consideration : Geographic restrictions

- APHIS considered geographic restrictions based upon geographic variation in plant pest risk. As presented in APHIS plant pest risk assessment

for Pioneer 305423 soybean , there is no g eographic differences in the plant pest risks for Pioneer 305423 soybean (USDA

- APHIS 2009). This alternative was rejected and not analyzed in detail because Pioneer 305423 soybean is unlikely to pose a plant pest risk and therefore, APHIS will have no reg ulatory authority over Pioneer 305423 soybean and will be unable to impose regulatory restrictions on this GE soybean variety.

Environmental Consequences of APHIS’ Selected Action

The EA contains a full analysis of the alternatives to which we refer the reader for specific details . The following table briefly summarizes the results for each of the issues fully analyzed in the Environmental Consequences section of the EA.

Table 1.

Attribute/Measure Alternative A

No Action Alternative B Deregulation in Wh ole (Preferred Alternative)

Meets APHIS Purpose and Need and Objectives No Yes

Unlikely to pose a plant pest

risk Satisfied through use of regulated field trials Satisfied

— risk assessment (USDA

- APHIS 2009)

Farmer choice Not available commercially No restrictions Soybean Gene Movement (Pollen

F low) Minimal Minimal

Weediness None None

Human Health Unchanged Unchanged

Animal Feed Unchanged Unchanged Agricu ltural Production of Soybean Growing Region and Acreage Unchanged Unchanged

Organic and Conventional Soybean Production Unchanged Unchanged

Herbicide Use Unchanged Unchanged Soybean Composition Oil Composition Unchanged FDA approved safety of

cha ngesPage 7 of 12 Soybean Meal Composition Unchanged Unchanged
Proximate, Isoflavones and

Antinutrients Unchanged Unchanged

Impacts on Non Target Organisms Toxicity and Allergenicity Unchanged Unchanged

Nutrition Unchanged Unchanged

Pest and Disease Unchanged U nchanged

Soil Communities Unchanged Unchanged Threatened and Endangered Species Unchanged Unchanged

Other Regulatory Approvals

U. S. Completion of FDA

consultation Completion of FDA

consultation Foreign Trade Approvals from Canada,

Mexico Approvals from Canada,

Mexico Compliance with Other

Laws CWW, CAA. EOs Fully compliant Fully compliant

Finding of No Significant Impact The analysis in the EA indicates that there will not be a significant impact, individually or cumulatively, on the quality of the human environment as a result of this proposed action. I agree with this conclusion and therefore find that an EIS need not be prepared. This NEPA determination is based on the following context and intensity factors (40 CFR 1508.27):

Context

– T he term “context” recognizes potentially affected resources, as well as the location and setting in which the environmental impact would occur. This action has potential to affect conventional and organic soybean production systems, including surrounding environments and agricultural workers ; human food and animal feed production systems; and foreign and domestic commodity markets. As identified in the Affected Environment section above, although the preferred alternative would allow for new plantings of DP

- 305423 soybean to occur anywhere in the U.S., the environmental analysis is limited to those areas that currently support soybean production

, predominantly focused in 17 states. Users of soybean products, both food and industrial products could be poten tially impacted by this action.

Intensity

– Intensity is a measure of the degree or severity of an impact based upon the ten factors. The following factors were used as a basis for this decision :

1. Impacts that may be both beneficial and adverse.

The advantageous and healthful properties of oil derived from the DP

- 305423 soybean and properties of the fatty acid ratios are in demand by food producers to replace to some extent oil products from existing lines of soybean

. ThePage 8 of 12 commercialization of Pion eer 305423 soybean could be beneficial for the consumer’s health. Increased intake of oils high in monounsaturated fatty acids, such as oleic acid have been shown to have positive effects on total cholesterol levels when compared to equal intakes of hydro genated oils (Lichtenstein et al. 2006). Likewise, increased intake of oils high in oleic acid can decrease LDL

cholesterol levels compared to equal intakes of saturated oils (Mensink et al. 1989) and increased HDL

- cholesterol levels compared to an equal intake of polyunsaturated oil (Mata et al. 1992). Moderate consumption of oil high in oleic acid has also demonstrated decreases in systolic blood pressure (Bondia

- Pons et

al. 2006). As identified in the response to comments, concern has been expressed

t hat if a sufficient amount of Pioneer 305423 soybeans inadvertently enters the commodity soybean supply stream and not the appropriate identity preserved food chain, the Nutrition Facts Panel of some products may not correctly reflect the fatty acid ratios

. As described in Chapter 5 of the EA, Pioneer 305423 soybean is expected to be adopted as a n adjunct to conventional commodity soybean oil, but

will b e marketed as a specialty soybean and grown under an identity preserved

process thereby reducing the pot ential of inadvertent mixing

. Granting nonregulated status to DP 305423 soybean will not impact agricultural acreage devoted to soybean production, and will likely only displace production of existing varieties. If this line is given non regulated status , there are no foreseeable changes to the availability of GE, conventional, organic or specialty soybean varieties on the market.

2. The degree to which the proposed action affects public health or safety. The proposed action to grant nonregulated status to DP

- 305423 soybean would have no significant impacts on human or animal health. High oleic acid event DP

305423 is not materially different in composition, safety, or any other relevant parameter from soybean now grown, marketed, and consumed , except f or the desired increases in oleic acid, and decreases in linoleic and linolenic acid

. Information presented in the petition suggests that b ecause alterations of these

common fatty acid s resemble ratios of fatty acids that are derived from other

oilseed cro ps, n o impacts were expected from the commercial sale or use of the

derived oils in foods

. As described in Chapter 5 o f the EA, s oybean varieties with

a lterations of fatty acid ratios are currently available to growers, including those

with elevated oleic acid . These crops have been used safely in the marketplace. FDA completed the safety and nutritional assessment for this product and had no further questions regarding the safety of Pioneer 305423 soybean (FDA 2009).

Based on the assessment of the la boratory evidence prov ided in the petition and accompanying scientific literature, APHIS has concluded that Pioneer 305423 soybean would have no significant impacts on human or animal health

. 3. Unique characteristics of the geographic area such as proxim ity to historic or cultural resources, park lands, prime farmlands, wetlands, wild and scenic rivers, or ecologically critical areas. There are no unique characteristics of geographic area such as park lands, prime farm lands, wetlands, wild and scenic are as, or ecologically critical areas that

w ould be significantly affected. DP

- 305423 will only be grown in areas suita ble for the production of soybean and those historically used for soybean production

.Page 9 of 12 There is no significant difference in performance or agricultural practices for the growth of DP

- 305423 soybean compared to other soybean varieties, and no natural resources or land usage will be significantly altered through the production of DP

- 305423 soybean

. 4. The degree to which the effects on the q uality of the human environment are likely to be highly controversial. The effects on the quality of the human environment are not highly controversial. Although there is some opposition to the granting of nonregulated status to DP

305423 soybean , this ac tion is not highly controversial in terms of size, nature or

effect. Other than objections to all genetically engineered crops, the public comments did not register any specific factual concerns with the data provided

APHIS for this crop and which were pr esented in the EA

. I nterest in maintaining product identity and separation was expressed, because some products might be affected by differences of DP

- 305423 soy oil from commodity soy oil

. The importance of company sponsored stewardship plans and manufa cturer surveillance of purchased oil is discussed in the APHIS response to comments.

5. The degree to which the possible effects on the human environment are highly uncertain or involve unique or unknown risks. The effects of the proposed non regulated sta tus for DP 305423 are not highly uncertain and do not involve unique or unknown risks. Based on the analysis

documented in the EA

, the effects on the human environment would not be significant. APHIS ha s no evidence for any unknown risks of this product when released for commercial production. As described in Chapter 5 of the EA and
response to comments , well established management practices, production controls, and production practices (GE, conventional, and organic) are currently being used in soybean production systems in the US. Therefore, it is reasonable to assume that farmers, who produce conventional soybean

, DP

- 305423 soybean

, or produce soybean using organic methods, will continue to use these reasonable, commonly accepted best management prac tices for their chosen system and varieties during agricultural soybean production. Additionally, most of the soybean acreage in the U.S. is planted to GE varieties. Of the total soybean acres planted in 2008, 92% were GE glyphosate tolerant soybean vari eties (USDA

NASS 2008 ). The availability of DP 305 423 soybean would offer growers and

manufacturers another choice of modified fatty acids in addition to the options already available.

6. The degree to which the action may establish a precedent for futu re actions with significant effects or represents a decision in principle about a future

consideration.

The proposed action would not establish a precedent for future actions with significant effects or represent a decision in principle about a future de cision

. Similar to past petitions for nonregulated status (http://www.aphis.usda.gov/brs/not_reg.html), the APHIS decision on the regulatory status of DP 305423 soybean will be based upon information provided in the applicant submitted petition. APHIS r egulations at 7 CFR part 340, regulate the introduction (importation, interstate movement, or release into the environment) of certain GE organisms and products. A person may petition thePage 10 of 12 agency to evaluate submitted data and determine that a particular r egulated article is unlikely to pose a plant pest risk, and, therefore, should no longer be regulated, under 7 CFR § 340.6 “Petition for Determination of Nonregulated Status.” After receipt of a petition, BRS makes an independent determination on whether an organism is unlikely to pose a plant pest risk and is therefore no longer subject to the regulatory requirements of 7 CFR part 340. Each petition that APHIS receives undergoes this independent review to determine if the regulated article poses a plant pest risk.

7. Whether the action is related to other actions with individually insignificant but cumulatively significant impacts. No significant cumulative effects were identified through this assessment. The

EA discussed cumulative effects on soybean management practices, human and animal health, and the environment and concluded that such impacts were not significant. A cumulative effects analysis is included in Chapter 5 of the EA.

8. The degree to which the action may adversely affect districts, sites, highways, structures, or objects listed in or eligible for listing in the National Register of Historic Places or may cause loss or destruction of significant scientific, cultural,

or historical resources.

DP 305423 soybean would have no impact on d istricts, sites, highways, structures, or objects listed in or eligible for listing in the National Register of Historic Places, nor would they likely cause any loss or destruction of significant scientific, cultural, or historical resources . Granting non regulated status to DP 305423 soybean will not cause an increase in agricultural acreage devoted to soybean cultiva tion, or to acres devoted to GE soybean cultivation because the product oil will replace some existing soybean oil, both conventional commodi ty soybean oil and specialty oils such as low linolenic oil

. DP

- 305423 soybean will

not alter geographic locations of future soybean production in the U.S. because the crop has production needs that are the same as th ose for conventional soybean.

9. The degree to which the action may adversely affect an endangered or threatened species or its habitat that has been determined to be critical under the Endangered Species Act of 1973. APHIS evaluated the potential for negative effects on federal t hreatened an d

e ndangered s pecies as listed by the U.S. Fish and Wildlife Service from

cultivation of 305423 soybean and its progeny and determined that the release of 305423 soybean

, following a determination of nonregulated status

, would have no

effect on federally l isted threatened or endangered species or species proposed for listing

, or on designated critical habitat or habitat proposed for designation (see section on Threatened and Endangered Species, pages 2 5

- 28 of the EA)

. 10. Whether the action threatens a vio lation of Federal, State, or local law or requirements imposed for the protection of the environment. The proposed action would be in compliance with all federal, state, and local

laws. T he proposed action to grant nonregulated status to DP

- 305423 and rem ove this GE soybean variety from APHIS’ regulatory oversight would be carried out in accordance with 7 CFR part 340. DP

- 305423 soybean has successfully completed the consultation process with the FDA concerning food and feed safetyPage 11 of 12 (Appendix 1 of the EA). DP

- 305423 soybean does not express any genetically engineered pesticides or tolerance to herbicides; thus EPA consultation is not required for this product. There are no other Federal, state, or local permits that are needed prior to the implementation of this action. A list of the current status of U.S. and international approvals is found in Table 1 of th is Decision

Document

.

Literature Cited:

Bondia

- Pons, I., Sc hro e der, H., Covas, M., Castellote, A.I., Kaikkonen, J., Poulsen, H.E., gaddi, A.V., Machowetz, A., Kiesewetter, H., and Lopez

- Sabater, C. (2006) Moderate consumption of olive oil by healthy European men reduces systolic blood pressure in non

- Mediterranean participants. J

. Nutrition 177, 84

- 87. FDA (2009) Biotechnology Consultation Note t o the file on soybean event 305423 (BNF No. 000110). http://www.fda.gov/Food/Biotechnology/Submissions/ucm155595.htm

. (Accessed 6/20/2009)

. Lichtenstein, A., Mathan, N.R., Jal bert, S.M., Resteghini, N.A., Schaefer, E. J

., and Ausman, L.M. (2006) Novel soybean oils with different fatty acid profiles alter cardiovascular disease risk factors in moderately hyperlipidemic subjects. Am. J.

Clin. Nutr. 84:497

- 504. Mata, P., Alvarez

- S ala, L.A., Rubio, M.J., and Oya, M.D. (1992) effects of long

- term
monounsaturated

- vs polyunsaturated

- enriched diets on lipoproteins in healthy

men and women. Am

. J

. C lin

. Nutr

. 55:846

- 850. Mensink, R.P., and Katan, M.B. (1989) Effect of a diet enriched with monounsaturated or polyunsaturated fatty acids on levels of low

- density and high density lipoprotein cholesterol in healthy women and men. New England Journal of Medicine 321

No 7.

USDA

- APHIS (2009) Plant Pest Risk Analysis for Pioneer 305423 soybean . USDA, APHIS, Biotechnology Regulatory Service. Riverdale, MD http://www.aphis.usda.gov/brs/not_reg.html

USDA

- NASS. (2008) Acreage. United States Department of Agriculture, National Agricultura l Statistics Service, Washington, D.C. http://usda.mannlib.cornell.edu/usda/current/Acre/Acre

- 06

- 30

- 2008.txtNEP A Decision and Rationale

I have carefully reviewed the EA prepared for this NEP A detennination and the input

from the public involvement process. I believe that the issues identified in the EA are best addressed by selecting Alternative B - Grant nonregulated status to Pioneer 305423 soybean, "in whole".

As stated in the CEQ regulations, "the agency's preferred alternative is the alternative

which the agency believes would fulfill its statutory mission and responsibilities, giving

consideration to economic, environmental, technical and other factors." The preferred

alternative has been selected for implementation based on consideration of a number of
environmental, regulatory, and social factors. Based upon our evaluation and analysis,

Alternative B is selected because (1) it allows APHIS to fulfill its statutory mission to
protect America's agriculture and environment using a dynamic and science-based regulatory framework that allows for the safe development and use of genetically engineered organisms; and (2) it allows APHIS to fulfill its regulatory obligations. Since

APHIS has concluded that that Pioneer DP 305423 soybean is unlikely to pose a plant

pest risk, APHIS has no authority to continue to regulate a GE organism once it has

detennined that the GE organism does not pose a plant pest risk. The comments
identified from public involvement did not change the results of the analysis. Therefore,

it is my decision to implement the preferred alternative as described in the EA.

# A(J,tU.J~ JUN 

## 7 2010 

# fo
Michael C. Gregoire Date Deputy Administrator Biotechnology Regulatory Services

Animal and Plant Health Inspection Services

U.S. Department of Agriculture